NCT01999049

Brief Summary

The Argus II Retinal Implant is a revolutionary new device, which offers vision to patients who are blind from retinal degeneration - retinitis pigmentosa. These patients have no alternatives. Patients typically can achieve ambulatory vision.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

November 25, 2013

Last Update Submit

April 23, 2015

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

  • Safety

    The primary endpoint in the study is safety. Safety will be assessed by calculating the proportion of subjects who experience individual procedure- and device-related adverse events. In addition, the proportion of subjects who experience a significant ocular event will also be reported.

    Patients will be observed for 1 year post-implant.

Secondary Outcomes (1)

  • Visual function

    1 year

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe to profound outer retinal degeneration

You may qualify if:

  • Adults, age 25 years or older with severe to profound outer retinal degeneration.
  • but some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation and previous history of useful form vision.

You may not qualify if:

  • Ocular diseases or conditions that could prevent the Argus II System from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus).
  • Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva, axial length \<20.5 mm or \> 26 mm, corneal ulcers, choroidal neovascularisation in the area of the intended tack location, etc.).
  • Ocular diseases or conditions (other than cataracts) that prevent adequate visualisation of the inner structures of the eye (e.g. corneal opacity, etc.).
  • Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery.
  • Predisposition to eye rubbing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHN Toronto Western Hospital 6E-438

Toronto, Ontario, M5t 2S8, Canada

RECRUITING

Related Publications (2)

  • Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.

    PMID: 22244176BACKGROUND

  • Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.

    PMID: 24049718BACKGROUND

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert Devenyi, MD

    University Health Network- Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Devenyi, MD

CONTACT

416-603-5602rdevenyi@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 3, 2013

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

CA(1)